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A Study of RO5185426 in Patients With Metastatic Melanoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 2, 2011
Last Update Posted: April 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
This open-label, multicenter study will evaluate the safety and efficacy of RO5185426 in patients with BRAF V600 mutation-positive, surgically incurable and unresectable stage IIIC or IV metastatic melanoma. Eligible patients will receive RO5185426 (960 mg twice daily orally) until disease progression or unacceptable toxicity occurs, with a safety follow-up of 24 months after discontinuation of the study drug.

Condition Intervention Phase
Malignant Melanoma Drug: RO5185426 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study to Assess the Safety of RO5185426 in Patients With Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

Secondary Outcome Measures:
  • Overall Response Rate, tumor assessments according to RECIST criteria [ Time Frame: 22 months ]

Enrollment: 3287
Study Start Date: March 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5185426
960 mg twice daily orally


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 16 years of age
  • Histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with BRAF V600 mutation determined by Cobas 4800 BRAF Mutation Test
  • Patients may or may not have received prior systemic therapy for metastatic melanoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Evidence of symptomatic CNS lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of RO5185426
  • Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
  • Concurrent administration of any anti-cancer therapies other than those administered in the study
  • Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
  • Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307397

  Hide Study Locations
Tirana, Albania, 1000
Buenos Aires, Argentina, C1280AEB
Buenos Aires, Argentina, C1425DTG
Buenos Aires, Argentina, C1426ANZ
Australia, New South Wales
North Sydney, New South Wales, Australia, 2060
Waratah, New South Wales, Australia, 2298
Westmead, New South Wales, Australia, 2145
Wodonga, New South Wales, Australia, 3690
Australia, Queensland
Greenslopes, Queensland, Australia, 4120
Townsville, Queensland, Australia, 4812
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Geelong, Victoria, Australia, 3220
Melbourne, Victoria, Australia, 3002
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Feldkirch, Austria, 6807
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4020
Salzburg, Austria, 5020
St. Pölten, Austria, 3100
Wien, Austria, 1090
Brussel, Belgium, 1090
Bruxelles, Belgium, 1200
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Rio de Janeiro, RJ, Brazil, 20230-130
Porto Alegre, RS, Brazil, 90035-003
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01509-010
São Paulo, SP, Brazil, CEP 01321-001
Plovdiv, Bulgaria, 4000
Sofia, Bulgaria, 1756
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
North Vancouver, British Columbia, Canada, V7L 2L7
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Quebec City, Quebec, Canada, G1R 2J6
Bogota, Colombia
Cali, Colombia
Medellin-Antioquia, Colombia
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 53
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Ostrava, Czech Republic, 708 52
Praha, Czech Republic, 128 00
Praha, Czech Republic
Aarhus C, Denmark, 8000
Herlev, Denmark, 2730
Odense, Denmark, 5000
Cuenca, Ecuador
Guayaquil, Ecuador, EC090104
Portoviejo, Ecuador, EC130104
Tallinn, Estonia, 11312
Tallinn, Estonia, 13419
Tartu, Estonia, 50406
Helsinki, Finland, 00029
Tampere, Finland, 33520
Turku, Finland, 20520
Aachen, Germany, 52074
Augsburg, Germany, 86179
Berlin, Germany, 12200
Bochum, Germany, 44791
Buxtehude, Germany, 21616
Chemnitz, Germany, 09117
Dresden, Germany, 01307
Düsseldorf, Germany, 40225
Erfurt, Germany, 99089
Erlangen, Germany, 91054
Essen, Germany, 45122
Frankfurt, Germany, 60596
Freiburg, Germany, 79104
Gera, Germany, 07548
Göttingen, Germany, 37075
Hamburg, Germany, 20246
Hannover, Germany, 30449
Heidelberg, Germany, 69115
Heilbronn, Germany, 74078
Jena, Germany, 07743
Kassel, Germany, 34125
Kiel, Germany, 24105
Köln, Germany, 50937
Leipzig, Germany, 04103
Ludwigshafen, Germany, 67063
Lübeck, Germany, 23538
Magdeburg, Germany, 39120
Mainz, Germany, 55131
Mannheim, Germany, 68167
Marburg, Germany, 35043
Minden, Germany, 32429
München, Germany, 80337
München, Germany, 80804
Münster, Germany, 48149
Münster, Germany, 48157
Nürnberg, Germany, 90419
Quedlinburg, Germany, 06484
Recklinghausen, Germany, 45657
Regensburg, Germany, 93053
Tübingen, Germany, 72076
Wiesbaden, Germany, 65191
Wuppertal, Germany, 42283
Würzburg, Germany, 97080
Athens, Greece, 115 27
Athens, Greece, 15123
Heraklion, Greece, 711 10
Piraeus, Greece, 18547
Budapest, Hungary, 1085
Budapest, Hungary, 1122
Debrecen, Hungary, 4012
Pecs, Hungary, 7632
Szeged, Hungary, 6720
Hyderabad, India, 500034
Lucknow, India, 226003
Mumbai, India, 400012
Nashik, India, 422004
New Delhi, India, 110085
Trivandrum, India, 695 011
Vellore, India, 632004
Cork, Ireland
Dublin, Ireland, 4
Dublin, Ireland, 7
Dublin, Ireland
Galway, Ireland
Limerick, Ireland
Waterford, Ireland
Beer Sheva, Israel, 8410101
Hafia, Israel, 3109601
Jerusalem, Israel, 91120-01
Ramat Gan, Israel, 5262100
Napoli, Campania, Italy, 80131
Meldola, Emilia-Romagna, Italy, 47014
Modena, Emilia-Romagna, Italy, 41100
Reggio Emilia, Emilia-Romagna, Italy, 42100
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00167
Roma, Lazio, Italy, 00168
Genova, Liguria, Italy, 16132
Bergamo, Lombardia, Italy, 24127
Brescia, Lombardia, Italy, 25123
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20141
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70126
Palermo, Sicilia, Italy, 90127
Firenze, Toscana, Italy, 50139
Pisa, Toscana, Italy, 50126
Siena, Toscana, Italy, 53100
Terni, Umbria, Italy, 05100
Padova, Veneto, Italy, 35128
Korea, Republic of
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Daugavpils, Latvia, 5417
Riga, Latvia, LV 1079
Klaipeda, Lithuania, 92288
Vilnius, Lithuania, 08661
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Leon, Mexico, 37000
Mexico City, Mexico, 14000
Mexico DF, Mexico, 06726
Amsterdam, Netherlands, 1066 CX
Amsterdam, Netherlands, 1081 HV
Blaricum, Netherlands, 1261 AN
Breda, Netherlands, 4818 CK
Groningen, Netherlands, 9713 GZ
Leiden, Netherlands, 2333 ZA
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6500 HB
Rotterdam, Netherlands, 3000 CA
Utrecht, Netherlands, 3584 CX
Bergen, Norway, 5021
Oslo, Norway, 0379
Arequipa, Peru, 04001
Lima, Peru, 34
Krakow, Poland, 31-531
Olsztyn, Poland, 10-228
Poznań, Poland, 60-693
Warszawa, Poland, 02-781
Lisboa, Portugal, 1099-023
Porto, Portugal, 4200-072
Bucuresti, Romania, 022328
Cluj-Napoca, Romania, 400058
Timisoara, Romania, 300167
Russian Federation
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 143423
Saint-Petersburg, Russian Federation, 197022
Saint-Petersburg, Russian Federation, 197758
Stavropol, Russian Federation, ND
UFA, Russian Federation, 450054
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Bratislava, Slovakia, 812 50
Bratislava, Slovakia, 833 10
Poprad, Slovakia, 058 01
Ljubljana, Slovenia, 1000
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7570
Cape Town, South Africa, 7700
Johannesburg, South Africa, 2196
Pretoria, South Africa, 0002
Sandton, South Africa, 2196
Oviedo, Asturias, Spain, 33011
Santander, Cantabria, Spain, 39008
Palma De Mallorca, Islas Baleares, Spain, 07014
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Cartagena (Murcia), Murcia, Spain, 30202
Pamplona, Navarra, Spain, 31008
Vigo, Pontevedra, Spain, 36312
La Laguna (Tenerife), Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08916
Cordoba, Spain, 14004
Granada, Spain, 18014
La Coruña, Spain, 15006
Leon, Spain, 24071
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Malaga, Spain, 29010
Salamanca, Spain, 37007
Sevilla, Spain, 41009
Valencia, Spain, 41014
Valencia, Spain, 46009
Zaragoza, Spain, 50009
Gothenburg, Sweden, SE-41 343
Lund, Sweden, 22185
Stockholm, Sweden, 171 76
Umeå, Sweden
Uppsala, Sweden, 75185
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Chur, Switzerland, 7000
Lausanne, Switzerland, 1011
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8091
Adana, Turkey, 01120
Adana, Turkey, 01330
Ankara, Turkey, 06230
Ankara, Turkey, 06500
Antalya, Turkey, 07000
Bornova, İZMİR, Turkey, 35100
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34000
Istanbul, Turkey, 34300
Istanbul, Turkey, 34365
Izmir, Turkey, 35340
Sıhhiye, ANKARA, Turkey, 06100
United Kingdom
Cambridge, United Kingdom, CB2 0QQ
Glasgow, United Kingdom, G12 0YN
Guildford, United Kingdom, GU2 7XX
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, SW3 6JJ
Manchester, United Kingdom, M20 4QL
Newcastle upon Tyne, United Kingdom, NE7 7DN
Northwood, United Kingdom, HA6 2RN
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Southampton, United Kingdom, SO16 6YD
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
First Submitted: February 17, 2011
First Posted: March 2, 2011
Last Update Posted: April 5, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas